10 Baby Deaths Associated with Teething Tablets, Says FDA

10 baby deaths are associated with the use of homeopathic teething tablets, according to an FDA statement on the adverse events sent via email:

“We are also aware of reports of 10 deaths during that time period [the last 6 years] that reference homeopathic teething products, though the relationship of these deaths to the homeopathic teething products has not yet been determined and is currently under review.”

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“The U.S. Food and Drug Administration is warning consumers that homeopathic teething tablets and gels may pose a risk to infants and children. The FDA recommends that consumers stop using these products and dispose of any in their possession. Homeopathic teething tablets and gels are distributed by CVS, Hyland’s, and possibly others, and are sold in retail stores and online. Consumers should seek medical care immediately if their child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething tablets or gels.”

After the FDA’s warning, CVS voluntarily removed all homeopathic teething products from their stores, including the following:

Baby Orajel Naturals Gel for Teething Pain, .33 oz

Baby Orajel Naturals Gel for Teething Pain Nighttime Formula, .33 oz

Baby Orajel Naturals Tablets for Teething Pain, 125 Count

CVS Homeopathic Infant’s Teething Tablet, 135 Count

CVS Homeopathic Infants’ Teething Liquid, .85 oz

Hyland’s Baby Nighttime Teething Tablets, 135 Count

Hyland’s Baby Teething Gel, .5 oz

Hyland’s Baby Teething Tablets, 13 Count

Hyland’s Baby Teething Tablets, 135 Count

Hyland’s Teething Gel, .33 oz

Homeopathic Teething Tablets Not Approved by the FDA

Homeopathic teething tablets and gels have not been evaluated or approved by the FDA for safety or efficacy, according to the FDA warning information. The FDA also noted that it “is also not aware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children.”

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If your baby was harmed by one of these products, you can contact our law firm to request a free consultation with an attorney. Attorneys Fred Pritzker, Brendan Flaherty and Lindsay Lien Rinholen are our lead lawyers for cases involving children harmed by defective products.

FDA Adverse Event Information

The FDA asks that the following be noted:

“While adverse event reports give us some information about a product and serious injuries or deaths related to use of a particular product, they often indicate situations that require additional analysis and do not constitute conclusive evidence of a problem with the product. Sometimes after further analysis, the adverse events may inform agency decisions to take regulatory action. Other times, further analysis shows that the adverse events were not attributable to a problem with the product but to other factors, such as a patient’s underlying health conditions. It also is important to note that the number of adverse events identified may fluctuate with our growing understanding of an issue, as well as through identification and elimination of duplicate reports.”